Method and apparatus for encapsulating a rigid insert in a contact lens for correcting vision in astigmatic patients

ABSTRACT

The present invention, as described above and as further defined by the claims below, provides methods for forming an Ophthalmic Lens that encapsulates a Rigid Insert, wherein the Rigid Insert may be tailored to correct specific astigmatic characteristics of an eye and apparatus for implementing such methods, as well as Ophthalmic Lenses formed with the Rigid Inserts.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 13/833,967, filed Mar. 15, 2013, publishedSep. 18, 2014, as US20140268021, the entire contents of which are herebyincorporated by reference.

FIELD OF USE

This invention describes methods, apparatus, and devices related toencapsulation aspects related to Ophthalmic Devices and, morespecifically, in some embodiments, the sealing and encapsulation aspectsin the fabrication of a contact lens for astigmatism.

BACKGROUND

Traditionally, an Ophthalmic Device, such as a Contact Lens or anintraocular Lens, included a biocompatible device with a corrective,cosmetic, or therapeutic quality. A Contact Lens, for example, canprovide one or more of vision-correcting functionality, cosmeticenhancement, and therapeutic effects. The physical characteristics ofthe Ophthalmic Lens provide each function. A design incorporating arefractive quality into an Ophthalmic Lens can provide avision-corrective function. A pigment incorporated into the OphthalmicLens can provide a cosmetic enhancement. An active agent incorporatedinto an Ophthalmic Lens can provide a therapeutic functionality.

Astigmatism is a common optical defect that is often the result ofirregular or toric curvature of the cornea or lens of the eye. As aresult, correcting vision for patients with astigmatism requires a morecomplex solution than the typical Contact Lens. More recently, it isdesirable therefore to have additional methods and apparatus conduciveto the formation of Ophthalmic Lenses that may correct vision inastigmatic patients. Recently, Rigid Inserts have been included inOphthalmic Lenses, wherein the Rigid Insert may add functionality to theOphthalmic Lens. Novel methods, devices, and apparatus relating to thesealing and encapsulation of a Rigid Insert within an Ophthalmic Lensare therefore important.

SUMMARY

Accordingly, the present invention includes innovations relating to anOphthalmic Lens device with a Rigid Insert capable of maskingastigmatism, the Ophthalmic Lens device comprising a lens comprising abiocompatible material, wherein the biocompatible material allows forplacement of the Ophthalmic Lens on an eye; a Rigid Insert, wherein thelens encapsulates the Rigid Insert; and a feature capable of correctingastigmatic vision, wherein the feature is located on one or both of thelens and the Rigid Insert. In some embodiments, the biocompatiblematerial may comprise a polymerized Reactive Monomer Mixture, including,for example, a hydrogel.

The Rigid Insert may include a plurality of zones, wherein each zonemirrors an astigmatic characteristic of the eye. In some embodiments,each zone may comprise a different material, wherein each materialenhances the effectiveness of the zone. The Rigid Insert may include athree-dimensional topography, for example, through a thermoformingprocess. The three-dimensional topography may mirror the astigmaticcharacteristic of the eye. The three-dimensional topography of the RigidInsert may be enhanced by a three-dimensional topography of the lens.

The Ophthalmic Lens may further comprise a Stabilizing Feature capableof orienting the Ophthalmic Lens on the eye, wherein the orientation iscapable of aligning the plurality of zones with the astigmaticcharacteristics of the eye. The Stabilizing Feature may be separate fromthe Rigid Insert or may be included in the Rigid Insert, for example,through a thermoforming process. In some embodiments, the StabilizingFeature may alter a front curve surface of the Ophthalmic Lens. Inothers, the Stabilizing Feature may add mass to the Ophthalmic Lens,wherein the mass is sufficient to ballast the Ophthalmic Lens. TheStabilizing Feature may further comprise a visual orientation cue,wherein the visual orientation cue is visible to the user and allows theuser to see how the Ophthalmic Lens should be oriented prior toplacement on the eye.

In some embodiments, the Ophthalmic Lens may provide multiplefunctionalities, in addition to correcting astigmatism. For example, thelens may further comprise a polarizing function or a cosmetic function,such as a patterned coloration. In some embodiment, the Rigid Insert mayfurther comprise an active agent, wherein the active agent is capable ofdissolving into an ophthalmic environment on the eye.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary embodiment of an Ophthalmic Lens with afully encapsulated Rigid Insert, wherein the Ophthalmic Lens may correctvision in astigmatic patients.

FIG. 2 illustrates an alternate FIG. 1 illustrates exemplary Moldassembly apparatus components that may be useful in implementing someembodiments of the present invention.

FIG. 3 illustrates exemplary Mold assembly apparatus components that maybe useful in implementing some embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention includes methods and apparatus for manufacturingan Ophthalmic Lens with a Rigid Insert, wherein the Rigid Insertcorrects vision in astigmatic patients. In addition, the presentinvention includes the resulting Ophthalmic Lens with the Rigid Insert.In general, according to some embodiments of the present invention, aRigid Insert may be integrated into an Ophthalmic Lens via automationthat places a Rigid Insert in a desired location relative to a Mold partused to fashion the Ophthalmic Lens.

Currently, Ophthalmic Lenses exist to correct astigmatism. For example,rigid gas permeable lenses may be placed over the cornea, and a tearlayer will form between the lens and the eye. The rigid gas permeablelens essentially acts as the new cornea, which may be designed to mimicthe curvature of a nonastigmatic eye. This technique is consideredmasking. However, the typical rigid gas permeable lens is uncomfortableand expensive.

Soft contact lenses provide a more comfortable and less expensivealternative. Unlike with an RGP, a tear layer may not form between theeye and the lens; so, a soft contact lens may be tailored to mirror theastigmatic characteristics of the eye. The lens may contain variedpowers and angles of refraction to correct each portion of the eye.However, because the lens is soft, the lens naturally conforms, to someextent, to shape of the eye. This reduces the effectiveness of the lens,and users often complain of blurriness or double vision.

The issues with comfort and effectiveness of either solution areexacerbated in patients with severe astigmatism. Accordingly, thepresent invention provides a novel alternative to correcting vision inastigmatic patients. An Ophthalmic Lens that may include a Rigid Insertis described, and more specifically, where an encapsulated Rigid Insertmay provide the correction to astigmatism.

In the following sections, detailed descriptions of embodiments of theinvention will be given. The description of both preferred andalternative embodiments are exemplary embodiments only, and it isunderstood that to those skilled in the art that variations,modifications, and alterations may be apparent. It is therefore to beunderstood that said exemplary embodiments do not limit the scope of theunderlying invention.

GLOSSARY

In this description and claims directed to the presented invention,various terms may be used for which the following definitions willapply:

Adhesion Promotion: as used herein refers to a process that increasesthe adhesive tendencies between two surfaces, such as, for example,between a Rigid Insert and an encapsulant.

Back Curve Piece or Back Insert Piece: as used herein refers to a solidelement of a Multi-piece Rigid Insert that, when assembled into the saidinsert, will occupy a location on the side of the Ophthalmic Lens thatis on the back. In an Ophthalmic Device, such a piece would be locatedon the side of the insert that would be closer to the wearer's eyesurface. In some embodiments, the Back Curve Piece may contain andinclude a region in the center of an Ophthalmic Device through whichlight may proceed into the wearer's eye. This region may be called anOptical Zone. In other embodiments, the piece may take an annular shapewhere it does not contain or include some or all of the regions in anOptical Zone. In some embodiments of an ophthalmic insert, there may bemultiple Back Curve Pieces, and one of them may include the OpticalZone, while others may be annular or portions of an annulus.

Component: as used herein refers to a device capable of drawingelectrical current from an Energy Source to perform one or more of achange of logical state or physical state.

Encapsulate: as used herein refers to creating a barrier to separate anentity, such as, for example, a Media Insert, from an environmentadjacent to the entity.

Encapsulant: as used herein refers to a layer formed surrounding anentity, such as, for example, a Media Insert, that creates a barrier toseparate the entity from an environment adjacent to the entity. Forexample, Encapsulants may be comprised of silicone hydrogels, such asEtafilcon, Galyfilcon, Narafilcon, and Senofilcon, or other hydrogelcontact lens material. In some embodiments, an Encapsulant may besemipermeable to contain specified substances within the entity andpreventing specified substances, such as, for example, water, fromentering the entity.

Energized: as used herein refers to the state of being able to supplyelectrical current to or to have electrical Energy stored within.

Energy: as used herein refers to the capacity of a physical system to dowork. Many uses within this invention may relate to the said capacitybeing able to perform electrical actions in doing work.

Energy Source: as used herein refers to a device capable of supplyingEnergy or placing a biomedical device in an Energized state.

Energy Harvesters: as used herein refers to device capable of extractingEnergy from the environment and convert it to electrical Energy.

Front Curve Piece or Front Insert Piece: as used herein refers to asolid element of a Multi-piece Rigid Insert that, when assembled intothe said insert, will occupy a location on the side of the OphthalmicLens that is on the front. In an Ophthalmic Device, such a piece wouldbe located on the side of the insert that would be further from thewearer's eye surface. In some embodiments, the piece may contain andinclude a region in the center of an Ophthalmic Device through whichlight may proceed into the wearer's eye. This region may be called anOptical Zone. In other embodiments, the piece may take an annular shapewhere it does not contain or include some or all of the regions in anOptical Zone. In some embodiments of an ophthalmic insert, there may bemultiple Front Curve Pieces, and one of them may include the OpticalZone, while others may be annular or portions of an annulus.

Lens-Forming Mixture or Reactive Mixture or Reactive Monomer Mixture(RMM): as used herein refers to a monomer or prepolymer material thatcan be cured and crosslinked or crosslinked to form an Ophthalmic Lens.Various embodiments may include Lens-Forming Mixtures with one or moreadditives such as, for example, UV blockers, tints, photoinitiators orcatalysts, and other additives useful in Ophthalmic Lenses such asContact or intraocular Lenses.

Lens-Forming Surface: as used herein refers to a surface that is used tomold an Ophthalmic Lens. In some embodiments, any such surface can havean optical quality surface finish, which indicates that it issufficiently smooth and formed so that an Ophthalmic Lens surfacefashioned by the polymerization of a Lens-Forming Mixture in contactwith the molding surface is optically acceptable. Further, in someembodiments, the Lens-Forming Surface can have a geometry that isnecessary to impart to the Ophthalmic Lens surface the desired opticalcharacteristics, including without limitation, spherical, aspherical andcylinder power, wave front aberration correction, corneal topographycorrection, or combinations thereof.

Lithium Ion Cell: as used herein refers to an electrochemical cell wherelithium ions move through the cell to generate electrical Energy. Thiselectrochemical cell, typically called a battery, may be Reenergized orrecharged in its typical forms.

Media Insert: as used herein refers to an encapsulated insert that willbe included in an energized Ophthalmic Device. The energization elementsand circuitry may be embedded in the Media Insert. The Media Insertdefines the primary purpose of the energized Ophthalmic Device. Forexample, in embodiments where the energized Ophthalmic Device allows theuser to adjust the optic power, the Media Insert may includeenergization elements that control a liquid meniscus portion in theOptical Zone. Alternatively, a Media Insert may be annular so that theOptical Zone is void of material. In such embodiments, the energizedfunction of the Lens may not be optic quality but may be, for example,monitoring glucose or administering medicine.

Mold: as used herein refers to a rigid or semi-rigid object that may beused to form Ophthalmic Lenses from uncured formulations. Some preferredMolds include two Mold parts forming a front curve Mold and a back curveMold.

Ophthalmic Lens or Ophthalmic Device or Lens: as used herein refers toany device that resides in or on the eye. The device may provide opticalcorrection, may be cosmetic, or provide some functionality unrelated tooptic quality. For example, the term Lens may refer to a contact Lens,intraocular Lens, overlay Lens, ocular insert, optical insert, or othersimilar device through which vision is corrected or modified, or throughwhich eye physiology is cosmetically enhanced (e.g. iris color) withoutimpeding vision. Alternatively, Lens may refer to a device that may beplaced on the eye with a function other than vision correction, such as,for example, monitoring of a constituent of tear fluid or means ofadministering an active agent. In some embodiments, the preferred Lensesof the invention may be soft contact Lenses that are made from siliconeelastomers or hydrogels, which may include, for example, siliconehydrogels and fluorohydrogels.

Optic Zone: as used herein refers to an area of an Ophthalmic Lensthrough which a wearer of the Ophthalmic Lens sees.

Power: as used herein refers to work done or energy transferred per unitof time.

Precure: as used herein refers to a process that partially cures amixture. In some embodiments, a precuring process may comprise ashortened period of the full curing process. Alternatively, theprecuring process may comprise a unique process, for example, byexposing the mixture to different temperatures and wavelengths of lightthan may be used to fully cure the material.

Predose: as used herein refers to the initial deposition of material ina quantity that is less than the full amount that may be necessary forthe completion of the process. For example, a predose may include aquarter of the necessary substance.

Postdose: as used herein refers to a deposition of material in theremaining quantity, after the predose, that may be necessary for thecompletion of the process. For example, where the predose includes aquarter of the necessary substance, a subsequent postdose may providethe remaining three quarters of the substance.

Rechargeable or Reenergizable: as used herein refers to a capability ofbeing restored to a state with higher capacity to do work. Many useswithin this invention may relate to the capability of being restored toa state with the ability to flow electrical current at a certain ratefor a certain, reestablished time period.

Recharge or Reenergize: as used herein refers to an act of restoring toa state with higher capacity to do work. Many uses within this inventionmay relate to restoring a device to a state with the capability to flowelectrical current at a certain rate for a certain, reestablished timeperiod.

Released from a Mold: as used herein refers to an act where anOphthalmic Lens is either completely separated from the Mold or is onlyloosely attached so that it can be removed with mild agitation or pushedoff with a swab.

Rigid Insert: as used herein refers to an insert that maintains apredefined topography. When included in a Contact Lens, the Rigid Insertmay contribute to the functionality and/or modulus of the Lens. Forexample, varying topography of or densities within the Rigid Insert maydefine zones, which may correct vision in users with astigmatism. TheRigid Insert may be flexible, for example the Rigid Insert may flexduring insertion and/or removal of the lens.

Stabilizing Feature: as used herein refers to a physical characteristicthat stabilizes an Ophthalmic Device to a specific orientation on theeye, when the Ophthalmic Device is placed on the eye. In someembodiments, the Stabilizing Feature may add sufficient mass to ballastthe Ophthalmic Device. In some embodiments, the Stabilizing Feature mayalter the front curve surface, wherein the eyelid may catch theStabilizing Feature and the user may reorient the Lens by blinking. Suchembodiments may be enhanced by including Stabilizing Features that mayadd mass. In some exemplary embodiments, Stabilizing Features may be aseparate material from the encapsulating biocompatible material, may bean insert formed separately from the molding process, or may be includedin the Rigid Insert or Media Insert.

Stacked Integrated Component Devices (SIC-Devices): as used hereinrefers to the product of packaging technologies that can assemble thinlayers of substrates, which may contain electrical and electromechanicaldevices, into operative integrated devices by means of stacking at leasta portion of each layer upon each other. The layers may compriseComponent devices of various types, materials, shapes, and sizes.Furthermore, the layers may be made of various device-productiontechnologies to fit and assume various contours.

Swellable Index: as used herein refers to the expandability or expandingtendency of a specific material during the manufacturing of anOphthalmic Lens.

Ophthalmic Lenses

Proceeding to FIG. 1, an exemplary embodiment Ophthalmic Lens 100 with aRigid Insert 110, wherein the Rigid Insert 110 includes physicalattributes that correct vision for patients with astigmatism, isillustrated. In some embodiments, a Rigid Insert 110 may mirror theastigmatic characteristics of the eye. For example, the Rigid Insert 110may include a first zone 111 with a first power and angle of refractionand a second zone 112 with a second power and angle of refraction. Insome embodiments, the first zone 111 may not be located exactly in thecenter of the eye, and the second zone 112 may not be radiallysymmetrical.

In such embodiments, Stabilizing Features 120 may be necessary toproperly orient the Ophthalmic Lens 100 on the eye. The StabilizingFeatures 120 may comprise a material that is different from theencapsulating Reactive Monomer Mixture. In some embodiments, thematerial for the Stabilizing Features 120 may be placed on a Front CurveMold Piece prior to placement of the Rigid Insert 110. Alternatively,the material may be injected into the Ophthalmic Lens 100 after theRigid Insert 110 has been placed between the Front Curve Mold Piece andthe Back Curve Mold Piece.

As shown in cross section, the Stabilizing Feature 120 may orient theOphthalmic Lens 100 on the eye by adding sufficient mass to anchor theOphthalmic Lens 100 to prevent rotation on the eye. In some alternativeembodiments, the Stabilizing Feature 110 may comprise a material with adifferent swellable index than the encapsulating RMM. In suchembodiments, the Stabilizing Feature 110 may swell during the process offorming the Ophthalmic Lens 100, wherein the swelling allows theStabilizing Feature 110 to alter the front surface topography of theOphthalmic Lens 100. When placed on the eye, the eyelid may catch theStabilizing Feature 110, and the user may reorient the lens by blinking.To further facilitate placement on the eye, the Stabilizing Feature 110may contain a tint, wherein the user may see how the Ophthalmic Lens 100may orient on the eye prior to placement.

In some embodiments a Rigid Insert may be formed by thermoforming analigned and held sheet into a three-dimensional shape that mayreplicates the surface of a thermoforming mold piece. The resultingpiece may be cut from the thin sheet of material. By positioning theRigid Insert within a cavity defined by front and back curve mold piecesand surrounding the insert with Reactive Monomer Mixture an OphthalmicLens may be formed. During the process of cutting out insert pieces fromthermoforming material, alignment features may be cut into the insertpiece such as notches, grooves, or flats for example. These features maybe used to align the insert piece or formed ophthalmic insert devices insubsequent processing.

Proceeding to FIG. 2, an alternative embodiment of an Ophthalmic Lens200 with a Rigid Insert 210, wherein the Rigid Insert 210 includesphysical attributes to correct vision in astigmatic patients, isillustrated. In patients with severe astigmatism, the Rigid Insert 210may include a complex configuration of zones 211-213, wherein each zone211-213 corrects vision for a specific portion of the eye. The RigidInsert 210 may be fully encapsulated in the Ophthalmic Lens 200 and maynot have direct contact with the eye. Accordingly, in some embodiments,the Rigid Insert 210 may comprise a variety of material, wherein thematerials may not be biocompatible. For example, a first zone 211 mayinclude a different material from a second 212 or third 213 zone. Theproperties of each material may increase the effectiveness of visioncorrection for each zone 211-213 or the properties alone may besufficient to correct the astigmatic characteristics. The properties mayinclude, for example, density or refractive index.

In some embodiments, the Rigid Insert 210 may be formed through athermoforming process. For example, in embodiments where each zone211-213 comprises a unique material, a thin sheet may be regionallycoated with each material. The thin sheet or a Rigid Insert cut from thethin sheet may be thermoformed to include a Three-dimensional Surface,wherein the topography of Three-dimensional Surface of the Rigid Insertcontributes to the correction of the astigmatic characteristics of theeye. In some embodiments, the Three-dimensional Surface may besufficient to create the necessary zones 211-213.

In some embodiments of Ophthalmic Lenses 200 that include Rigid Inserts210 with multiple zones, and particularly where the Rigid Insert 210includes complex variation, Stabilizing Features 220 may be includedwith the Rigid Insert 210. This may allow for precise alignment betweenthe Stabilizing Features 220 and the Rigid Insert 210. In some specificembodiments where the Rigid Insert 210 may be thermoformed, the RigidInsert may be cut from the thin sheet to include the StabilizingFeatures 220, as shown in cross section where the Stabilizing Feature220 extends from the Rigid Insert 220.

Similar to FIG. 1, the Stabilizing Feature 220 may alter the frontsurface topography so the user may reorient the Ophthalmic Lens 200 byblinking, or, in some embodiments, the Stabilizing Feature 220 may addsufficient mass to orient the Ophthalmic Lens 200 on the eye. Some otherembodiments may include a combination of mass and altered front surfacetopography. The Stabilizing Features 220 may include furthercharacteristics that may assist the user in properly orienting theOphthalmic Lens 200. For example, the Stabilizing Feature 220 mayinclude an inscription or tinting to indicate to the user how theOphthalmic Lens 200 may be placed on the eye.

In some embodiments, other passive elements may be included with theRigid Insert 210. In some embodiments, the Rigid Insert 210 may includepolarizing elements that may reduce glare, which may increase visionsharpness. In some embodiments, the Rigid Insert 210 may include aprinted pattern that may add cosmetic functionality, including aconcealment of the zones 211-213 on the Rigid Insert 210. In someembodiments, the Rigid Insert 210 may include an active agent that maydissolve when the Ophthalmic Lens 200 is placed on the eye. Embodimentswhere the active agent is a medicament may be particularly significantwhere the astigmatism is caused by damage to the eye.

Proceeding to FIG. 3, exemplary processing steps for forming anOphthalmic Lens 309 with a Rigid Insert 304, wherein the Rigid Insert304 is encapsulated and may be capable of correcting astigmatic vision,are illustrated. Exemplary materials and curing specifications areincluded in Table 1, but other materials and polymerization techniquesmay be apparent and are within the scope of the described inventive art.At 310, a front curve Mold 301 may be predosed with Reactive MonomerMixture 303. In some embodiments, Stabilizing Features 302 may bedeposited on the front curve Mold 301 or on the predosed RMM 303.

At 320, a Rigid Insert 304 may be placed proximate to the front curveMold 304 and in contact with the predosed RMM, wherein the placementforms a front curve assembly 301-304. In embodiments where theStabilizing Feature 302 is separate from the Rigid Insert 304, the RigidInsert 304 may be aligned with the Stabilizing Feature 302 and placed toallow proper orientation of the Ophthalmic Lens 309 when the OphthalmicLens 309 is placed on an eye.

At 330, the front curve assembly 301-304 may be postdosed with ReactiveMonomer Mixture 305, wherein the predose amount 303 and the postdoseamount 305 may fully encapsulate the Rigid Insert 304 and properly forman Ophthalmic Lens 308. At 340, a back curve Mold 306 may be placedproximate to the front curve Mold 301, wherein the front curve Mold 301and the back curve Mold 306 may form a lens-forming cavity 308. Thelens-forming cavity 308 may combine the postdosed RMM 305 and predosedRMM 303, which may allow the RMM 307 to fully encapsulate the RigidInsert 304.

In some embodiments, the RMM 307 may adhere to or at least partiallyencapsulate the Stabilizing Features 303. The front curve and back curveassembly 301-307 may be polymerized, for example through a curingprocess, to form the Ophthalmic Lens 309. At 350, the Ophthalmic Lens309 may be removed from the molding apparatus 301, 306.

TABLE 1 Partial Listing of exemplary sealing materials, encapsulatingmaterials and coating materials Material Exemplary aspects of utilityEpoxy One Component - high temp cure, excellent adhesive, Systemsbiocompatible Two Component - fast cure at ambient, biocompatibility,gap filling Silicone One Component - resistance to humidity, highSystems flexibility, Insulation, Optical Clarity Two Component -Strength, Superior Flexibility, biocompatibility UV Curable Fast Cure,grades with Flexibility, vapor free Systems LED Curable One Component,Low Temperature applications Systems Polyurethanes Optical Clarity,Insulation, Flexibility Polysulfides Underwater cure, high Strength,high chem resistance Cyanoacrylates Biocompatibility, single compound,no outgassing Elastomeric Excellent water resistance, Insulation, singleSystems compound Film Adhesives Preform-ability, excellent insulationcharacteristics Hot Melt Systems Food Contact Grades Latex SystemsPressure Sensitive Applications, Food Contact Grades PolyimidesPhotosensitive, Preform-ability, Flexibility Parylenes (Vapor SurfaceTreatment, Insulation, Conformal Application Phase Film Dep)

Elements may be formed from materials that may or may not be stable inthe environments that Ophthalmic Devices occupy, including, for example,the tear fluid on an ocular surface that contacts the element. The usemay include forming encapsulation layers from coatings, including, forexample, a parylene family including, but not limited to, the paryleneC, N, and D family elements. In some embodiments, the encapsulationcoating may occur before or after application of other adhesive orsealant layers.

Methods and Materials for Insert Based Ophthalmic Lenses

Referring back to FIG. 3, exemplary processing steps for forming anOphthalmic Lens 309 with a Rigid Insert 304, wherein the Rigid Insert304 is encapsulated and may be capable of correcting astigmatic vision,are illustrated. As used herein, a Mold apparatus 301, 306 may include aplastic formed to shape a lens-forming cavity 308 into which aLens-Forming Mixture 307 may be dispensed, and, upon reaction or cure ofthe Lens-Forming Mixture 307, an Ophthalmic Lens 309 of a desired shapeis produced. The combination of Mold parts 301, 306 is preferablytemporary, wherein, upon formation of the Ophthalmic Lens 309, the Moldparts 301, 306 may be separated for removal, at 350, of the OphthalmicLens 309.

At least one Mold part 301, 306 may have at least a portion of itssurface in contact with the Lens-Forming Mixture 307 so that uponreaction or cure of the Lens-Forming Mixture 307 the surface provides adesired shape and form to the portion of the Ophthalmic Lens with whichit is in contact. The same is true of at least one other Mold part 301,306.

Thus, for example, in an exemplary embodiment a Mold apparatus 301, 306is formed from two parts 301, 306, a female concave piece (front curveMold) 301 and a male convex piece (back curve Mold) 306 with a cavity308 formed between them. The portion of the concave surface that makescontact with a Lens-Forming Mixture 307 has the curvature of the frontcurve of an Ophthalmic Lens 309.

Said portion is sufficiently smooth and formed such that the surface ofan Ophthalmic Lens 309, formed by polymerization of the Lens-FormingMixture 307 that is in contact with the concave surface, is opticallyacceptable. In some embodiments, the front curve Mold 301 may also havean annular flange integral to and surrounding a circular circumferentialedge that extends from the front curve Mold 301 in a plane normal to theaxis and also extends from the flange (not shown).

A Lens-Forming Surface can include a surface with an optical-qualitysurface finish, which indicates that it is sufficiently smooth andformed so that an Ophthalmic Lens surface fashioned by thepolymerization of a Lens-Forming Mixture 308 in contact with the moldingsurface is optically acceptable. Further, in some embodiments, theLens-Forming Surfaces of the Mold pieces 301, 306 may have a geometrythat is necessary to impart to the Ophthalmic Lens surface the desiredoptical characteristics, including, but not limited to, spherical,aspherical, and cylinder power; wave front aberration correction;corneal topography correction; and combinations thereof. One ordinarilyskilled in the art will recognize that characteristics other than thosediscussed may also be included within the scope of the invention.

Some additional embodiments include a Rigid Insert 304 that may be fullyencapsulated within a hydrogel matrix. A Rigid Insert 304 may bemanufactured, for example, using microinjection molding technology.Embodiments can include, for example, a poly(4-methylpent-1-ene)copolymer resin with a diameter of between about 6 mm to 10 mm and afront surface radius of between about 6 mm and 10 mm and a rear surfaceradius of between about 6 mm and 10 mm and a center thickness of betweenabout 0.050 mm and 0.5 mm. Some exemplary embodiments include an insertwith diameter of about 8.9 mm and a front surface radius of about 7.9 mmand a rear surface radius of about 7.8 mm and a center thickness ofabout 0.100 mm and an edge profile of about 0.050 radius. One exemplarymicromolding machine can include the Microsystem 50 five-ton systemoffered by Battenfield Inc. Some or all of the sealing features,including, but not limited to, grooves, slots, lips, and knife edges maybe formed during the molding process or formed later by subsequentprocessing of the result of the molding process.

The Rigid Insert 304 may be placed in a Mold part 301, 306 utilized toform an Ophthalmic Lens 308. Mold part 301, 306 material can include,for example, a polyolefin of one or more of the following:polypropylene, polystyrene, polyethylene, polymethyl methacrylate, andmodified polyolefins. Other Molds can include a ceramic or metallicmaterial.

Other Mold materials that may be combined with one or more additives toform an Ophthalmic Lens Mold include, for example, Zieglar-Nattapolypropylene resins (sometimes referred to as znPP); a clarified randomcopolymer for clean molding as per FDA regulation 21 CFR (c) 3.2; arandom copolymer (znPP) with ethylene group.

Still further, in some embodiments, the Molds of the invention maycontain polymers such as polypropylene, polyethylene, polystyrene,polymethyl methacrylate, modified polyolefins containing an alicyclicmoiety in the main chain, and cyclic polyolefins. This blend can be usedon either or both Mold halves. Preferably, this blend is used on theback curve, and the front curve consists of the alicyclic co-polymers.

In some embodiments, an Ophthalmic Lens type may include an OphthalmicLens that includes a silicone-containing Component. Asilicone-containing Component is one that contains at least one [—Si—O—]unit in a monomer, macromer, or prepolymer. Preferably, the totalsilicone and attached oxygen are present in the silicone-containingComponent in an amount greater than about 20 weight percent, and morepreferably greater than 30 weight percent of the total molecular weightof the silicone-containing Component. Useful silicone-containingComponents preferably comprise polymerizable functional groups such asacrylate, methacrylate, acrylamide, methacrylamide, vinyl, N-vinyllactam, N-vinylamide, and styryl functional groups.

In some embodiments, the Ophthalmic Lens skirt, also called an insertencapsulating layer, that surrounds the insert may be comprised ofstandard hydrogel Ophthalmic Lens formulations. Exemplary materials withcharacteristics that may provide an acceptable match to numerous insertmaterials may include, but are not limited to, the Narafilcon family(including Narafilcon A and Narafilcon B), and the Etafilcon family(including Etafilcon A). A more technically inclusive discussion followson the nature of materials consistent with the art herein. Oneordinarily skilled in the art may recognize that other material otherthan those discussed may also form an acceptable enclosure or partialenclosure of the sealed and encapsulated inserts and should beconsidered consistent and included within the scope of the claims.

Suitable silicone-containing Components include compounds of Formula I

wherein R¹ is independently selected from monovalent reactive groups,monovalent alkyl groups, or monovalent aryl groups, any of which mayfurther comprise functionality selected from hydroxy, amino, oxa,carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate, halogen orcombinations thereof; monovalent siloxane chains comprising 1-100 Si—Orepeat units that may further comprise functionality selected fromalkyl, hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido,carbamate, halogen, or combinations thereof;

where b is 0 to 500, where it is understood that when b is other than 0,b is a distribution having a mode equal to a stated value;

wherein at least one R¹ comprises a monovalent reactive group and, insome embodiments, between one and three R¹ comprise monovalent reactivegroups.

As used herein, monovalent reactive groups are groups that can undergofree radical and/or cationic polymerization. Non-limiting examples offree radical reactive groups include (meth)acrylates, styryls, vinyls,vinyl ethers, C₁₋₆alkyl(meth)acrylates, (meth)acrylamides,C₁₋₆alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides,C₂₋₁₂alkenyls, C₂₋₁₂alkenylphellyls, C₂₋₁₂alkenylnaphthyls,C₂₋₆alkenylphenylC₁₋₆alkyls, O-vinylcarbamates, and O-vinylcarbonates.Non-limiting examples of cationic reactive groups include vinyl ethersor epoxide groups and mixtures thereof. In one embodiment the freeradical reactive groups comprise (meth)acrylate, acryloxy,(meth)acrylamide, and mixtures thereof.

Suitable monovalent alkyl and aryl groups include unsubstitutedmonovalent C₁₋₁₆alkyl groups, C₆₋₁₄ aryl groups, such as substituted andunsubstituted methyl, ethyl, propyl, butyl, 2-hydroxypropyl,propoxypropyl, polyethyleneoxypropyl, combinations thereof, and thelike.

In one embodiment b is 0, one R¹ is a monovalent reactive group, and atleast three R¹ are selected from monovalent alkyl groups having 1 to 16carbon atoms or, in another embodiment, from monovalent alkyl groupshaving 1 to 6 carbon atoms. Non-limiting examples of silicone Componentsof this embodiment include2-methyl-2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propoxy]propylester (“SiGMA”),2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane,3-methacryloxypropyltris(trimethylsiloxy)silane (“TRIS”),3-methacryloxypropylbis(trimethylsiloxy)methylsilane, and3-methacryloxypropylpentamethyl disiloxane.

In another embodiment, b is 2 to 20, 3 to 15 or, in some embodiments, 3to 10; at least one terminal R¹ comprises a monovalent reactive groupand the remaining R¹ are selected from monovalent alkyl groups having 1to 16 carbon atoms or, in another embodiment, from monovalent alkylgroups having 1 to 6 carbon atoms. In yet another embodiment, b is 3 to15, one terminal R¹ comprises a monovalent reactive group, the otherterminal R¹ comprises a monovalent alkyl group having 1 to 6 carbonatoms, and the remaining R¹ comprise monovalent alkyl group having 1 to3 carbon atoms. Non-limiting examples of silicone Components of thisembodiment include (mono-(2-hydroxy-3-methacryloxypropyl)-propyl etherterminated polydimethylsiloxane (400-1000 MW)) (“OH-mPDMS”), andmonomethacryloxypropyl terminated mono-n-butyl terminatedpolydimethylsiloxanes (800-1000 MW) (mPDMS).

In another embodiment, b is 5 to 400 or from 10 to 300, both terminal R¹comprise monovalent reactive groups, and the remaining R¹ areindependently selected from monovalent alkyl groups having 1 to 18carbon atoms, which may have ether linkages between carbon atoms and mayfurther comprise halogen.

In one embodiment, where a silicone hydrogel Ophthalmic Lens is desired,the Ophthalmic Lens of the present invention will be made from aReactive Mixture comprising at least approximately 20 and preferablybetween approximately 20 and 70 percent weight silicone-containingComponents based on total weight of reactive monomer Components fromwhich the polymer is made.

In another embodiment, one to four R¹ comprises a vinyl carbonate orcarbamate of Formula II

wherein Y denotes O—, S— or NH—; and R denotes hydrogen or methyl; d is1, 2, 3, or 4; and q is 0 or 1.

The silicone-containing vinyl carbonate or vinyl carbamate monomersspecifically include1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane;3-(vinyloxycarbonylthio) propyl-[tris(trimethylsiloxy)silane];3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate;3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate;trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinylcarbonate, and

Where biomedical devices with modulus below approximately 200 aredesired, only one R¹ shall comprise a monovalent reactive group and nomore than two of the remaining R¹ groups will comprise monovalentsiloxane groups.

Another class of silicone-containing Components includes polyurethanemacromers of the following formulae:(*D*A*D*G)_(a)*D*D*E¹;E(*D*G*D*A)_(a)*D*G*D*E¹ or;E(*D*A*D*G)_(a)*D*A*D*E¹  Formulae IV-VIwherein D denotes an alkyl diradical, an alkyl cycloalkyl diradical, acycloalkyl diradical, an aryl diradical, or an alkylaryl diradicalhaving 6 to 30 carbon atoms;

wherein G denotes an alkyl diradical, a cycloalkyl diradical, an alkylcycloalkyl diradical, an aryl diradical or an alkylaryl diradical having1 to 40 carbon atoms and which may contain ether, thio or amine linkagesin the main chain;

* denotes a urethane or ureido linkage;

_(a) is at least 1; and

A denotes a divalent polymeric radical of formula:

wherein R¹¹ independently denotes an alkyl or fluoro-substituted alkylgroup having 1 to 10 carbon atoms, which may contain ether linkagesbetween carbon atoms; y is at least 1; and p provides a moiety weight of400 to 10,000; each of E and E¹ independently denotes a polymerizableunsaturated organic radical represented by Formula VIIIwherein R¹² is hydrogen or methyl; R¹³ is hydrogen, an alkyl radicalhaving 1 to 6 carbon atoms, or a —CO—Y—R¹⁵ radical wherein Y is —O—,Y—S— or —NH—; R¹⁴ is a divalent radical having 1 to 12 carbon atoms; Xdenotes —CO— or —OCO—; Z denotes —O— or —NH—; Ar denotes an aromaticradical having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or1; and z is 0 or 1.

A preferred silicone-containing Component is a polyurethane macromerrepresented by Formula IX (the full structure may be understood byjoining corresponding asterisk regions, * to *, ** to **)

wherein R¹⁶ is a diradical of a diisocyanate after removal of theisocyanate group, such as the diradical of isophorone diisocyanate.Another suitable silicone-containing macromer is a compound of formula X(in which x+y is a number in the range of 10 to 30) formed by thereaction of fluoroether, hydroxy-terminated polydimethylsiloxane,isophorone diisocyanate and isocyanatoethylmethacrylate. Formula X (thefull structure may be understood by joining corresponding asteriskregions, * to *)

Other silicone-containing Components suitable for use in this inventioninclude macromers containing polysiloxane, polyalkylene ether,diisocyanate, polyfluorinated hydrocarbon, polyfluorinated ether, andpolysaccharide groups; polysiloxanes with a polar fluorinated graft orside group having a hydrogen atom attached to a terminaldifluoro-substituted carbon atom; hydrophilic siloxanyl methacrylatescontaining ether and siloxanyl linkages and crosslinkable monomerscontaining polyether and polysiloxanyl groups. Any of the foregoingpolysiloxanes can also be used as the silicone-containing Component inthis invention.

CONCLUSION

The present invention, as described above and as further defined by theclaims below, provides methods for forming an Ophthalmic Lens thatencapsulates a Rigid Insert, wherein the Rigid Insert may be tailored tocorrect specific astigmatic characteristics of an eye and apparatus forimplementing such methods, as well as Ophthalmic Lenses formed with theRigid Inserts.

The invention claimed is:
 1. An ophthalmic lens device for placement onan eye comprising: a lens comprising a biocompatible material; and arigid insert encapsulated within said lens and comprising a plurality ofzones wherein at least one of the plurality of zones mirrors anastigmatic characteristic of the eye and wherein said zones comprisediffering refractive indices; and wherein the rigid insert comprises oneor more materials having different densities among the plurality ofzones.
 2. The ophthalmic lens device of claim 1, wherein said lens has athree-dimensional topography.
 3. The ophthalmic lens device of claim 2,wherein the three-dimensional topography of the lens enhances acorrective property of the rigid insert.
 4. The ophthalmic lens deviceof claim 2, wherein said stabilizing feature orients the lens device toalign the three-dimensional topography of the rigid insert with theastigmatic vision characteristics of the eye.
 5. The ophthalmic lensdevice of claim 1, wherein the stabilizing feature alters the frontcurve surface of the lens.
 6. The ophthalmic lens device of claim 5,wherein the stabilizing feature projects from the front curve surface ofthe lens.
 7. The ophthalmic lens device of claim 1, wherein thestabilizing feature adds sufficient mass to ballast the ophthalmic lensdevice.
 8. The ophthalmic lens device of claim 1, wherein at least oneof the rigid insert and lens provide polarization.
 9. The ophthalmiclens device of claim 1, wherein at least one of the rigid insert andlens comprises a region of coloration.
 10. The ophthalmic lens device ofclaim 1, wherein said rigid insert further comprises an active agent.